Evenity is manufactured by Takeda Pharmaceutical Company [1].
Who makes Evenity?
Takeda Pharmaceutical Company is the manufacturer of Evenity [1].
What is Evenity used for?
Evenity is a medication used to treat osteoporosis in postmenopausal women who are at high risk for fracture [2]. It is also indicated for the treatment of osteoporosis in men who are at high risk for fracture [3].
How does Evenity work?
Evenity, also known as romosozumab, is a sclerostin inhibitor [4]. It works by increasing bone formation and decreasing bone resorption [5]. This dual mechanism helps to strengthen bones and reduce the risk of fractures [4].
When was Evenity approved?
Evenity received its first approval in Japan in January 2019 [6]. In the United States, it was approved by the Food and Drug Administration (FDA) in April 2019 [2].
What are the side effects of Evenity?
Common side effects of Evenity may include joint pain, headache, and reactions at the injection site [2]. A significant concern associated with Evenity is an increased risk of serious cardiovascular events, such as heart attack and stroke, which can occur after the drug is no longer taken [3][7]. Because of this risk, Evenity is contraindicated in patients who have had a myocardial infarction or stroke within the preceding 12 months [3].
Can Evenity be used with other osteoporosis medications?
Evenity is typically used for a limited duration, often up to 12 months, and is not generally recommended for use with other anabolic agents [2]. Following treatment with Evenity, patients are usually transitioned to antiresorptive therapy [4].
What is the availability and cost of Evenity?
Evenity is available by prescription and is administered by a healthcare professional as a subcutaneous injection [2]. The cost of Evenity can vary depending on insurance coverage and geographic location. Information on pricing is typically available through pharmacies or directly from the manufacturer [8].
What are the patent and exclusivity details for Evenity?
Information regarding the patents and exclusivity periods for Evenity can be found on DrugPatentWatch.com [9]. These details are crucial for understanding when generic versions of the drug might become available.
Who are Evenity's competitors?
Other medications used to treat osteoporosis include bisphosphonates (e.g., alendronate, risedronate), denosumab (Prolia), and teriparatide [10]. These drugs work through different mechanisms and have varying risk-benefit profiles [4][10].
What clinical data supports Evenity's use?
Clinical trials, such as the FRAME and ARCH studies, have demonstrated Evenity's efficacy in increasing bone mineral density and reducing fracture risk in postmenopausal women and men with osteoporosis [5][7]. However, these studies also highlighted the cardiovascular risks associated with the drug [7].
Patient concerns regarding Evenity
Patients and healthcare providers often discuss the balance between Evenity's bone-building benefits and the potential cardiovascular risks [7]. Careful patient selection and monitoring are essential for safe and effective use [3].
Sources:
[1] https://www.takeda.com/
[2] https://www.fda.gov/drugs/postmarket-drug-safety-information-for-patients-and-providers/evenity-romosozumab-risk-myocardial-infarction-stroke-and-cardiovascular-death
[3] https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761074s000lbl.pdf
[4] https://www.nejm.org/doi/full/10.1056/NEJMoa1700434
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6241801/
[6] https://www.amgen.com/news/2019/01/amgen-announces-japanese-ministry-of-health-labour-and-welfare-approval-of-evenity-romosozumab-for-the-treatment-of-osteoporosis/
[7] https://www.nejm.org/doi/full/10.1056/NEJMoa1713410
[8] https://www.goodrx.com/evenity
[9] https://drugpatentwatch.com/
[10] https://www.uptodate.com/contents/treatment-of-osteoporosis-in-postmenopausal-women-beyond-the-basics